Matthew Sieber Email & Phone Number

Baltimore, Maryland, United States

Baltimore, Maryland, United States

- Manages department section to achieve goals in accordance with established policies and tomeet schedules and/or resolve problems.- Initiate and facilitate the generation and/or review and approval of all department documents such as IB/DSUR annual updates, SOPs, department templates, study protocols, and related documents.- Responsible for the external vendor selection process, review/development of RFIs, budget and contract negotiations, and oversight of vendors for assigned studies through use of KPIs.- Support clinical development strategy related to regulatory approvals of new products.- Oversee study protocol development, timelines, quality, and budgets.- Contribute to site assessment and selection, negotiation and management of site budgets,and project training.- Drive ongoing risk management and contingency planning to ensure on-time delivery of the final study report.- Work with CRO, vendor partners, and functional areas on complex issues to develop and implement mitigations to achieve resolution.- Participate in both external and internal inspections and audits, provide guidance to project team, and drive prompt responses to questions and inquires.- Provide Leadership Team with updates/status reports on study execution, program milestones, and achievements.- Initiate and participate in staff hiring decisions, training, goal setting, performance monitoring, and performance reviews for all clinical development staff.- Establish department goals in support of corporate strategic imperatives and work with team members to identify and track individual goals.- Drive business strategy from an operational perspective.- Act as primary escalation point for all operational issues on study assignments.- Participate and support necessary governing forums.- Monitor staff performance and provide constructive feedback and coaching.

Baltimore, Maryland, United States

- Oversees tactical implementation of the clinical development plan by managing the timeline, resources, budget, and staff of clinical activities- Guide study team(s) in vendor selection and provide management oversight throughout the life of all assigned clinical projects. Proposes vendors for approval.- Ensures operational feasibility of clinical development plans and scenarios, including time, budget, and resource requirements.- Manages and leads day-to-day clinical trial activities related to the development and execution of cross functional and third party vendor activities and deliverables, including but not limited to, development and/or review of clinical data management conduct (e.g. edit check specifications, database build, query resolution, and database cleaning), relevant study plans, protocol review for operational feasibility and consistency, tracking site selection and activation and patient recruitment and tracking to project timelines- Develops, maintains and promotes effective and collaborative working relationships with and among internal team members and external- Participates and drives clinical operations initiatives and programs, including identifying areas of best practice and recommends process improvements, development of SOPs and department level training and cross project initiatives- Prepares and oversees the maintenance of Trial Master File (TMF) for multiple trials, ensuring tracking of ICH-GCP and/or FDA CRF21 essential study documents. - Leads reviews of key data to identify trends, discrepancies, errors, etc. to ensure ongoing quality of conduct in accordance with the protocol and vendor contracts, including on-going review of emerging data for tables, listings and figures- Support financial oversight of clinical studies through invoice tracking and reconciliation of change orders- Support and drive critical development and review of key study documents (e.g. protocol, ICF, study plans, eCRF, etc.)

Baltimore, Maryland Area

- Recognize, exemplify and adhere to ICON's values which centers around commitments to People, Clients, and Performance- As a Global Project Manager, create a culture of process improvement with a focus on streamlining processes to add value to the business while meeting client needs- Primary point of contact for designated projects and responsible for developing successful working relationships with clients- Responsible for cross functional project planning, scheduling and implementation of cross functional projects- Responsible for defining and adhering to project scope, resource requirements and deliverables- Develop and maintain cross functional project management plans- Responsible for risk mitigation strategies, associated action plan and issue resolution- Responsible for managing cross-functional project team, including all necessary project training is provided to assigned staff- Provide direction and support to project team- Manage projects in accordance with the contract- Proactively manage any study budget including changes in scope- Collaborate with Business Development to ensure timely completion of change orders- Manage study invoicing procedures- Track Project deliverables using appropriate tools- Effectively monitor and report on progress of the project to all stakeholders- Implement QC activities as necessary and monitor required quality metrics- Develop a succession plan for core team members and, in the event of a change to the team, ensure an effective hand-over- Maintain confidentiality of management information, as appropriate- Participate in business development activities- Travel domestic and/or international approximately 25% to meet the expectations and needs of both the business and client

Baltimore, Maryland Area

Project Leadership and Delivery:- Responsible for overseeing a project or program of projects in a metrics driven environment while adhering to all agreed upon timelines and budgetary agreements- Responsible for financial health of all projects including oversight of monthly revenue recognition activities based on unit achievement calculations, change order maintenance through to execution, task burn rate and profitability trend analysis- Manages a project as a Global Project Manager overseeing interdisciplinary clinical research programs ensuring compliance with Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs) and regulatory requirements. - Acts as primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer's and the Company's contractual agreement.- Leads clinical team to ensure quality, timelines, and budget management.- Accountable for financial performance of assigned projects.- Accountable for all project deliverables for assigned projects and/or project regions.- Coordinates activities and deliverables of all project conduct partners and proactively identifies and manages issues.Management:- Trains and supports new Project Managers and clinical monitoring staff. Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specifics, and process training.

Baltimore, Maryland Area

- Oversee interdisciplinary clinical research programs.- Represent Syneos Health to the customer, ensuring satisfaction levels are maintained and program deliverables are communicated effectively.- Lead clinical team to ensure quality, timelines, and budget management.- Responsible for TMF Management Plan and quality completeness of TMF for assigned projects.- Accountable for the financial performance of each project assignment.- Accountable for all project deliverables for each project assignment.- Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.- Ensure studies are conducted in compliance with GCP, relevant SOP's and regulatory requirements.- Accountable for maintenance of study information on a variety of databases and systems.- Responsible for study management components of inspection readiness for all aspects of the study conduct.- Oversight for development and implementation of project plans.- Plan, coordinate, and present at internal and external meetings.- Direct the activities of assigned Project Support staff.- Prepare project management reports for clients and management.- Implement resource strategies to achieve project goals.- Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals.- Participate in bid defense meetings where presented as potential project manager.- Support proposal development through review of proposal text and pricing where presented as potential project manager.

Baltimore, Maryland Area

- Responsible for client relationship management, day-to-day management of all elements of clinical operations including CRA oversight and training, vendor selection and management, maintenance of study and site level documentation, execution of tasks within contracted timelines, analysis of resource projections, and adherence to budget and contractual obligations. - Responsible for the management of study start up activities including the development of all study documents, contract templates, coordination of contractual agreements with sites and vendors, and assurance of inspection-ready regulatory documentation.- Management of CRA and LCRA teams to ensure the timely execution of all project deliverables- Management of study updates and communications released to the sites, vendors, and sponsors- Management of all project financials including client and vendor invoices, change order maintenance, and investigator grant payments.

Baltimore, Maryland Area

- Lead CRA for Phase III studies responsible for logistical management including in-house CRA oversight, on-site visit coordination and resource management, quality event escalation and resolution, monthly budget reporting, and trip report review.- Primary point-of-contact for client, upper management, vendors, and clinical team.- Leader of client meetings and facilitator of all internal updates.

Baltimore, Maryland Area

- Lead CRA for Phase I and III studies responsible for overall CRA management and oversight.- Acted as liaison with all functional areas to ensure timely reporting of operational metrics and accurate forecasting of resourcing needs.- Management of communication with trial vendors, medical monitors, and clinical teams.- Recruitment leader responsible for advertising, proposal review, follow-up, budget negotiations, and contract amendment coordination for multiple Phase III trials.- Presenter and organizer of multiple investigator meetings for both national and international trials.

Baltimore, Maryland Area

- Functioned as an on-site monitor specializing in conducting all forms of monitoring visits including Pre-Study, Site Initiation, Routine Monitoring, and Study Close-Out.- Responsible for source data verification across multiple studies and databases.- Responsible for training and mentoring clinical research staff, both on-site and remotely.- Integral role in study start-up activities specifically related to the site feasibility control process, monitoring plan development, report template construction, IRB submissions and approvals, site regulatory documentation, quality control, and source document creation.

Blue Bell, Pennsylvania

- Responsible for in-house support of on-site monitors, co-monitoring, and trial master file maintenance.- Responsible for the review and tracking of protocols, amendments, and informed consents from development through IRB/EC approval.- Key role in database lock preparation for national and international studies.- Quality control assurance for multiple databases and tracking systems.- Developer of multiple reference guides for monitoring, safety related events, and deviation tracking.

Provided simultaneous translation services for various EUROHYPO AG lending transactions; Primary author/editor and English language coach to the Berlin Branch President in preparation for the delivery of the commercial lending group’s annual report; Translation work, including real estate investment proposals, zoning issues, closing documents, and real estate portfolio reviews; Understanding of German lending requirements for commercial and residential real estate transactions both in Germany and abroad; Working knowledge of German real estate banking laws and credit procedures, specifically bank covenants; General command of the international banking program, IRIS (integrated risk management)

Responsible for client financial data entry and contributing author for credit approval reports; Performed market research of the proposed sites of continuing care retirement communities, including locations, demographics, and existing retirement facilities; Developed data tracking system in Excel for current clients using both demographic and revenue specific reporting formats; General command of Moody’s business software and working knowledge of the continuing care retirement community market

Ba, German Studies

Activities and Societies: German Club, Masters Swimming Club, Campus School Marathon TeamI spent my Junior year studying German.

Certificate In Accounting Fundamentals, Accounting

The Certificate in Accounting Program provides the coursework necessary to sit for the CPA Exam in 2016. My intention in completing this.